This study is designed to assess the effect of PF-06865571 administration on the pharmacokinetics of metformin in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Metformin
PF-06865571
Pfizer Clinical Research Unit
Brussels, Belgium
Maximum Observed Plasma Concentration (Cmax) of Metformin (in absence of PF-06865571)
Metformin Cmax in absence of PF-06865571
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hours post-dose
Metformin Cmax (in presence of PF-06865571)
Metformin Cmax in presence of PF-06865571
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Metformin (in absence of PF-06865571)
Metformin AUCinf in absence of PF-06865571
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hours post-dose
Metformin AUCinf (in presence of PF-06865571)
Metformin AUCinf in presence of PF-06865571
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hours post-dose
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Treatment-related AE are any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to study drug is assessed either yes or no by the investigator. Participants with multiple occurrences of an AE within a category are counted once within the category.
Time frame: Baseline up to 35 days after last dose of study medication
Number of Participants With Laboratory Abnormalities
The following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity \[pH\], glucose, protein, blood, ketones, microscopy \[if urine tested positive for blood or protein\]).
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Time frame: Baseline up to 35 days after last dose of study medication
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
the following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure and pulse rate.
Time frame: 0 and 48 hours (h) post-dose
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Absolute values and changes from baseline for ECG parameters
Time frame: 0 and 48 h post-dose